The peer‑reviewed pharmacokinetic study of TONMYA was published in Clinical Pharmacology in Drug Development on February 28 2026. The paper, titled “Single‑Dose Pharmacokinetic Assessment of TNX‑102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open‑Label Studies in Healthy Volunteers,” provides independent validation of the drug’s sublingual formulation.
The study demonstrates that the sublingual tablets achieve rapid absorption and a 154 % relative bioavailability compared with oral immediate‑release cyclobenzaprine. The rapid absorption and higher bioavailability are attributed to the proprietary basifying agent that enables transmucosal delivery and bypasses first‑pass hepatic metabolism, thereby reducing exposure to the active metabolite norcyclobenzaprine.
Tonix CEO Seth Lederman highlighted that the pharmacokinetic profile underpins the drug’s design to increase parent drug exposure during sleep while limiting side‑effects from the long‑half‑life metabolite. He noted that the study confirms the company’s objective to improve the durability of cyclobenzaprine’s analgesic effect by decreasing liver production of norcyclobenzaprine.
TONMYA, approved by the FDA on August 15 2025 and launched in the U.S. in November 2025, is the first new fibromyalgia treatment approved in more than 15 years. The independent validation of its pharmacologic advantages strengthens Tonix’s commercial positioning as it seeks to capture market share in a market dominated by older therapies.
The publication reinforces the company’s narrative that its sublingual formulation offers a unique therapeutic approach targeting non‑restorative sleep, a key symptom of fibromyalgia. By demonstrating superior pharmacokinetics, Tonix bolsters its competitive edge and supports future growth prospects in the fibromyalgia treatment space.
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